Screen problems with Thoratec HeartMate systems have been linked to dozens of patient injuries, in the latest recall impacting the product.
Manufacturer indicates that healthcare professionals should keep an alternative left ventricle assist device (LVAD) on standby in the event of a Heartmate 3 failure.
The FDA has announced yet another recall for HeartMate left ventricle assist systems, which have been linked to serious problems in recent years, and may have contributed to dozens of patient deaths.
FDA has classified problems with the communication system as a Class 1 HeartMate recall, indicating that continued use of the device may pose a risk of serious injuries or death.
